EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11656/2020 
(POOL/E4/2020/11656/11656 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving active chlorine generated from sodium chloride by electrolysis as an active 
substance for use in biocidal products of product -type 1  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving active chlorine generated from sodium chloride by electrolysis as an active 
substance for use in biocidal products of product -type 1  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 9 (1)(a)  thereof,   
Whereas:  
(1) On 31 July 2007, t he competent authority of Slovakia  (“the evaluating competent 
authority”) received  an application, in accordance with Article 11(1) of Directive 
98/8/EC  of the European Parliament and of the Council2, for the inclusion of the active 
substance active chlorine generated from sodium chloride by electrolysis  in Annex I to 
that Directive for use  in biocidal products of product -type 1, human hygiene , as 
defined in Annex V to that Directive, which correspond s to product -type 1 as defined 
in Annex V to Regulation (EU) No 528/2012.  
(2) On 19 November 2010,  the evaluating competent authority  submitted the assessment 
report together with its conclusions to the Commission in accordance with Article 
11(2) of Directive  98/8/EC . 
(3) On 16 June 2020 , the Biocidal Products Committee adopted the opinion of the 
European Chemicals Agency3 (‘the Agency’ ), having regard to the conclusions of the 
evaluating competent authority.  
(4) According to that opinion, bi ocidal products of product -type 1 using  active chlorine 
generated from sodium chloride by electrolysis  may be expected to satisfy the 
requirements laid down in Ar ticle 5 of Directive 98/8/EC , provided that certain 
specifications and conditions concerning their use are complied with.  
(5) Taking into account the opinion  of the Agency, it is appropriate to approve active 
chlorine generated from sodium chloride by electrol ysis as an active substance for use 
in bi ocidal products of product -type 1 subject to compliance with certain 
specifications and conditions.  
(6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocid al Products,  
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market  (OJ L 123, 24.4.1998, p. 1) . 
3 Biocidal Products Committee Opinion on the application for approval of the active substance active 
chlorine generated from sodium chloride by electrolysis , Product type:1 , ECHA /BPC/ 250 adopted on 
16 June 2020.  EN 2  EN HAS ADOPTED THIS REGULATION:  
Article  1 
Active chlorine generated from sodium chloride by electrolysis  is approved as an active 
substance for use in biocidal products of product -type 1 subject to the specifications and 
conditions set out in the  Annex.  
Article  2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN